FDA 510(k)

Optimus ALIF System

K-Number: K160291 · 2016-02-18

Decision Date2016-02-18

Product CodeOVD

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Optimus ALIF System is a medical device manufactured by Amendia, Inc.. It received FDA 510(k) clearance on 2016-02-18 under approval number K160291. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Optimus ALIF System?

Optimus ALIF System is a medical device that received FDA 510(k) clearance on 2016-02-18. It is manufactured by Amendia, Inc.. The 510(k) number is K160291.

When was Optimus ALIF System approved by the FDA?

Optimus ALIF System received FDA 510(k) clearance on 2016-02-18, under approval number K160291.

What company makes Optimus ALIF System?

Optimus ALIF System is manufactured by Amendia, Inc..

What is the FDA product code for Optimus ALIF System?

The FDA product code for Optimus ALIF System is OVD.

Other Devices by Amendia, Inc.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.